Alcohol Use DisorderPhase 2NCT04873453
CBD for the Treatment of Alcohol Use Disorder
A Phase 2 study testing Cannabidiol in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 31 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be between 21-60 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Currently seeking treatment for AUD.
- If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening.
- Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening.
- Live within 35 miles of the study site.
Who cannot join
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Use nicotine daily.
- Self-report use of cocaine, amphetamines, opioids, cannabis, or benzodiazepines in the last 30 days.
- Report having or being treated for a current DSM-V Axis I diagnosis, including major depression, panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
- Endorsing an item on the RMTS-S measure of suicide risk.
- Currently taking any of the following medications:
Show all 15Show fewer
- Those known to have a major interaction with Epidiolex.
- Acute treatment with any antiepileptic medications.
- Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
- Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Tolerability and Efficacy of Hemp-Derived CBD for the Treatment of Alcohol Use Disorder
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
Read the detailed description
The current study will directly test the hypothesis that a moderate dose of cannabidiol (CBD) leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects. The hypotheses are grounded in previous studies suggesting that CBD reduces the reinforcing properties of alcohol and decreases drinking motivation and consumption (Viudez-Martínez, García-Gutiérrez, Fraguas-Sánchez, et al., 2018). Further, CBD has shown clinical promise for tobacco, cannabis, and opioid use disorders (Hurd, 2017; Hurd et al., 2015; Prud'homme et al., 2015), and evidence indicates that these effects may be due to the ability of CBD to reduce cue-induced craving and anxiety (Gonzalez-Cuevas et al., 2018; Hurd et al., 2019). The hypotheses are also grounded in the pre-clinical literature suggesting that CBD may modulate the immune system and have anti-inflammatory effects which also helps to reduce harm associated with alcohol and may have a positive effect on those attempting to quit. Other potential mechanisms that might underlie the effects of CBD include a reduction in the severity of acute withdrawal, a reduction in protracted withdrawal, and the neuroprotective effects of CBD. Given the background literature with respect to CBD and AUDs, a logical next step is for human studies to address these questions.
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
To minimize risk of COVID transmission, the investigators will utilize Zoom for weekly subject check-ins and our Mobile Pharmacology Lab (MPL) for the collection of blood samples and clinical data for the majority of in-person visits. The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be MPL follow-up visits at Weeks 1, 4, and 8. Participants will be contacted by Zoom each remaining week during the 8-week period. A follow up Zoom interview will occur in Week 16 approximately 8 weeks after the end of dosing.
Overall, the clinical study is expected to take 1-2 years to complete enrollment and data analysis.
- Conditions
- Alcohol Use Disorder
- Being tested
- Cannabidiol, Placebo
- Keywords
- Alcohol, Cannabidiol, CBD, Cannabis
- Medical subject headings
- Alcoholism, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.
PlaceboDrug
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Full-spectrum Cannabidiol | Active comparator | 150mg/day of full-spectrum cannabidiol, containing less than 0.3%THC. Receives: Drug: Cannabidiol |
| Broad-spectrum Cannabidiol | Experimental | 150mg/day of broad-spectrum cannabidiol, containing 0%THC. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | 150mg/day of hemp-seed oil with no cannabinoids present. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Measured: 0-8 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Measured: 0-16 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Measured: 0-4 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Measured: 4-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Measured: 0-16 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Measured: 4-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Measured: 0-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Measured: 0-4 weeks
Secondary outcomes (15)
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Measured: 0-4 weeks
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Measured: 4-8 weeks
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006) .
Measured: 0-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Measured: 0-4 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Measured: 4-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Measured: 0-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Measured: 0-16 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Measured: 0-4 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Measured: 4-8 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Measured: 0-8 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Measured: 0-16 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Measured: 0-16 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Measured: 0-8 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Measured: 4-8 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start30 Aug 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo-controlled, parallel group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873453
- Sponsor's protocol ID
- 20-2694
- Status last verified
- Sep 2024
- First submitted
- 20 Apr 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller RL, Hooper JF, Ellingson JM, Olsavsky AK, Rzasa-Lynn R, Bryan AD, Bidwell LC, Hutchison KE. A preliminary randomized trial of the safety, tolerability, and clinical effects of hemp-derived cannabidiol in alcohol use disorder. Front Psychiatry. 2025 Apr 28;16:1516351. doi: 10.3389/fpsyt.2025.1516351. eCollection 2025.
PubMed 40357520
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Efficacy of Hemp-Derived CBD for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04873453
- Acronym / sponsor ID
- 20-2694
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Cannabidiol, CBD, Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
Detailed description
The current study will directly test the hypothesis that a moderate dose of cannabidiol (CBD) leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects. The hypotheses are grounded in previous studies suggesting that CBD reduces the reinforcing properties of alcohol and decreases drinking motivation and consumption (Viudez-Martínez, García-Gutiérrez, Fraguas-Sánchez, et al., 2018). Further, CBD has shown clinical promise for tobacco, cannabis, and opioid use disorders (Hurd, 2017; Hurd et al., 2015; Prud'homme et al., 2015), and evidence indicates that these effects may be due to the ability of CBD to reduce cue-induced craving and anxiety (Gonzalez-Cuevas et al., 2018; Hurd et al., 2019). The hypotheses are also grounded in the pre-clinical literature suggesting that CBD may modulate the immune system and have anti-inflammatory effects which also helps to reduce harm associated with alcohol and may have a positive effect on those attempting to quit. Other potential mechanisms that might underlie the effects of CBD include a reduction in the severity of acute withdrawal, a reduction in protracted withdrawal, and the neuroprotective effects of CBD. Given the background literature with respect to CBD and AUDs, a logical next step is for human studies to address these questions.
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
To minimize risk of COVID transmission, the investigators will utilize Zoom for weekly subject check-ins and our Mobile Pharmacology Lab (MPL) for the collection of blood samples and clinical data for the majority of in-person visits. The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be MPL follow-up visits at Weeks 1, 4, and 8. Participants will be contacted by Zoom each remaining week during the 8-week period. A follow up Zoom interview will occur in Week 16 approximately 8 weeks after the end of dosing.
Overall, the clinical study is expected to take 1-2 years to complete enrollment and data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a double-blind, placebo-controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Full-spectrum Cannabidiol | Active comparator | Drug: Cannabidiol150mg/day of full-spectrum cannabidiol, containing less than 0.3%THC. |
| Broad-spectrum Cannabidiol | Experimental | Drug: Cannabidiol150mg/day of broad-spectrum cannabidiol, containing 0%THC. |
| Placebo | Placebo comparator | Drug: Placebo150mg/day of hemp-seed oil with no cannabinoids present. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be between 21-60 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Currently seeking treatment for AUD.
- If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening.
- Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening.
Key exclusion criteria (15 listed)
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Use nicotine daily.
- Self-report use of cocaine, amphetamines, opioids, cannabis, or benzodiazepines in the last 30 days.
- Report having or being treated for a current DSM-V Axis I diagnosis, including major depression, panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
- Endorsing an item on the RMTS-S measure of suicide risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDThe current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. | Drug | Broad-spectrum Cannabidiol, Full-spectrum Cannabidiol |
| PlaceboPlacebo arm | Drug | Placebo |
Primary outcome
Drinks per Drinking Day
Time frame: 0-8 weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Drinks per Drinking Day
Time frame: 0-16 weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Drinks per Drinking Day
Time frame: 0-4 weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Drinks per Drinking Day
Time frame: 4-8 weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Alcohol Dependence/Craving
Time frame: 0-16 weeks
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Alcohol Dependence/Craving
Time frame: 4-8 weeks
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Alcohol Dependence/Craving
Time frame: 0-8 weeks
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Alcohol Dependence/Craving
Time frame: 0-4 weeks
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
15 secondary outcomes
Cue-reactivity
Time frame: 0-4 weeks
Cue-reactivity
Time frame: 4-8 weeks
Cue-reactivity
Time frame: 0-8 weeks
Anxiety
Time frame: 0-4 weeks
Anxiety
Time frame: 4-8 weeks
Anxiety
Time frame: 0-8 weeks
Anxiety
Time frame: 0-16 weeks
Subjective Pain Level
Time frame: 0-4 weeks
Subjective Pain Level
Time frame: 4-8 weeks
Subjective Pain Level
Time frame: 0-8 weeks
Subjective Pain Level
Time frame: 0-16 weeks
Sleep Quality
Time frame: 0-16 weeks
Sleep Quality
Time frame: 0-8 weeks
Sleep Quality
Time frame: 4-8 weeks
Sleep Quality
Time frame: 0-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40357520Mueller RL, Hooper JF, Ellingson JM, Olsavsky AK, Rzasa-Lynn R, Bryan AD, Bidwell LC, Hutchison KE. A preliminary randomized trial of the safety, tolerability, and clinical effects of hemp-derived cannabidiol in alcohol use disorder. Front Psychiatry. 2025 Apr 28;16:1516351. doi: 10.3389/fpsyt.2025.1516351. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks per Drinking Day (time frame: 0-8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.